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Senior Business Analyst

Katalyst Healthcares & Life Sciences

  • Warren, NJ
  • 22 days ago

    Highlights

    The role is responsible for gathering business requirements, creating user stories, designing workflows, ensuring CSV alignment, and serving as the liaison between Business and IT teams in a GxP-regulated environment. Job Summary: We are seeking a Senior Business Analyst Veeva Vault Quality to support Business & Technology Integration for Veeva Quality Docs/QMS implementation within the Life Sciences domain.

    Numbers & Facts

    LocationWarren, NJ

    Description

    Job Summary:
    • We are seeking a Senior Business Analyst Veeva Vault Quality to support Business & Technology Integration for Veeva Quality Docs/QMS implementation within the Life Sciences domain.
    • The role is responsible for gathering business requirements, creating user stories, designing workflows, ensuring CSV alignment, and serving as the liaison between Business and IT teams in a GxP-regulated environment.
    Roles & Responsibilities:
    • Drive end-to-end business analysis across Veeva Quality Docs and QMS implementation and enhancement projects.
    • Gather, document, and validate business and functional requirements for Veeva Quality Docs and QMS modules.
    • Convert quality processes into user stories, use cases, and functional specifications.
    • Plan and lead workshops and interviews with stakeholders across Quality Assurance, Regulatory Affairs, and Compliance.
    • Align stakeholder groups on project scope and priorities while managing competing interests.
    • Partner with Veeva technical consultants and configuration teams to ensure accurate delivery of requirements.
    • Support the design of document lifecycle workflows and training record structures within Quality Docs.
    • Ensure alignment with GxP, 21 CFR Part 11, and CSV compliance principles.
    Education & Experience:
    • 10+ years of experience with Veeva Vault Quality Docs/QMS.
    • 10+ years of Business Analysis experience within the Pharmaceutical/Life Sciences industry.
    • 6+ years of experience with GxP, 21 CFR Part 11, and CSV compliance.
    • Experience with stakeholder management across QA and Regulatory Affairs.
    • Experience in document lifecycle workflow design.
    • Veeva Vault Certification is preferred.
    • Strong written and verbal communication skills.

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